Application 063011

Type: ANDA
Sponsor: ZYDUS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 50MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A063011-001	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1992-03-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A063011-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A063011-001	MINOCYCLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-02	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A063011-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063011-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063011-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063011-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063011-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063011-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063011-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063011-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063011-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063011-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063011-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063011-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063011-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A063011-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063011-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063011-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063011-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063011-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063011-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063011-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063011-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A063011-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A063011-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A063011-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A063011-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A063011-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A063011-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A063011-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A063011-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A063011-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A063011-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A063011-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A063011-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A063011-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A063011-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A063011-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A063011-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A063011-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A063011-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A063011-001	AB	1	`cb3db0bc1861…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Northwind Health Company, LLC	f33fcfd2-b9ef-8e67-e053-2a95a90a0306	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063011 application number: ANDA063011
Minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	25acb785-6838-4e62-9e86-ddc30b2b759a	2025-04-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063011 application number: ANDA063011 ndc (product): 68382-316
Minocycline hydrochloride	MINOCYCLINE HYDROCHLORIDE	Zydus Lifesciences Limited	26ee99af-f44b-4076-a08c-0a0dedc9edfe	2024-10-03		Exact identifier application applno (ANDA): 063011 application number: ANDA063011 ndc (product): 70771-1426

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68382-316	Minocycline hydrochloride	Minocycline hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-316	Minocycline hydrochloride	Minocycline hydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-316	Minocycline hydrochloride	Minocycline hydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
70771-1426	Minocycline hydrochloride	Minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1426	Minocycline hydrochloride	Minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1426	Minocycline hydrochloride	Minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1426	Minocycline hydrochloride	Minocycline hydrochloride	Zydus Lifesciences Limited	ANDA	Current
70771-1426	Minocycline hydrochloride	Minocycline hydrochloride	Cadila Healthcare Limited	ANDA	Current